Please complete the CAPTCHA to continue
@mallinckrodt.com
✓
2 phones found area 124
✓
LinkedIn matched
A concise factual answer block for searchers comparing this professional profile.
Heather R. E. is listed as Compliance Manager | Strategic Thinker | Relationship Builder | Executor | Mentor | Pharmaceutical Industry at Mallinckrodt Pharmaceuticals, a with 3453 employees, based in Greater St. Louis, United States. AeroLeads shows a work email signal at mallinckrodt.com, phone signal with area code 124, and a matched LinkedIn profile for Heather R. E..
Heather R. E. previously worked as Compliance Manager at Mallinckrodt Pharmaceuticals and Sr. Controlled Substances Compliance Coordinator, Legal at Mallinckrodt Pharmaceuticals. Heather R. E. holds Master Of Business Administration - Mba, Business Administration And Management, General from Western Governors University.
This section adds company-level context without repeating Heather R. E.'s masked contact details.
AeroLeads found 1 current-domain work email signal for Heather R. E.. Compare company email patterns before reaching out.
A strategic thinker, relationship builder, and executor by nature, I support enterprise compliance health in a highly regulated environment by developing, implementing, and executing compliance programs with continuous improvement. With over 13 years of experience in the pharmaceutical industry in the compliance arena, I thrive and enjoy learning new areas of compliance, leveraging and celebrating the unique abilities of others to create dynamic teams, and execute to build new and sustainable compliance programs. As part of my academic journey, I received my MBA from Western Governors University and put that knowledge to the test by incorporating strategies and tactical plans into my compliance focus and driving it to completion. I seek to be the solution by simply asking, “how can I help you today?”. My top 5 Gallup strengths:Learner: I flourish in dynamic work environments where I am expected to become a subject matter expert in a short period of time. The process of learning excites me, and I am energized gaining new competencies.Individualization: I am a keen observer of other people’s unique strengths and draw them out to build productive teams to let them shine.Relator: For me, relationships have value only if they are genuine. Be who you are, and everything will fall into place. Analytical: I rigorously seek to understand the “why” and peel back the layers to understand the root cause.Focus: My focus forces me to evaluate and filter actions that move towards the goal and to keep others focused on the destination. How can I help you today?
Listed skills include Pharmaceutical Industry, Dea, Quality Control, Quality Assurance, and 45 others.
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
Manage third party intermediary anti-bribery / anti-corruption due diligence investigationsSupport Opioid Business Operating Injunction on our opioid operationsSupport risk assessment and mitigation plan (RAMP) programManaged Data Privacy project assessing risk and introduced a new compliance frameworkSupport annual Code of Conduct certification and conflict of interest process
Saint Louis, Missouri
Managed quota consumption process through continuous monitoring and collaboration with Manufacturing and Planning personnel to remain within quota limits for 34 individual quotas and maintain regulatory and business operations compliance.Contributor to development and execution of the St. Louis Plant Year-End Report (YER) and Quota Consumption processes.Annual audit of 70 individual YERs with internal discrepancy investigations and corrective action implementations.Presented Quota Roadshow, New Hire Orientation, and annual controlled substances year-end inventory trainings to educate St. Louis Plant stakeholders in areas of controlled substances compliance and security.Developed and reviseed Drug Enforcement Administration (DEA) Alcohol and Tobacco Tax Trade Bureau SOPs and guidance documents for process standardization and continued business compliance.Supported DEA and Missouri Board of Pharmacy Regulatory Inspections by serving as a controlled substance compliance SME and drive follow-up action items.Performed cross-functional compliance responsibilities with State Reporting, ARCOS reporting, Witness Destructions, and Exportations.Assisted with complex quota requests and submissions.Continued industry education and active participant at the National Association of Drug Diversion Investigators (NADDI) Annual Missouri Chapter training and National Conference.
Hazelwood, Missouri
Managed Suspicious Order Monitoring (SOM) program assessing enterprise compliance risks on a daily, monthly, and annual basis through investigations and data analytics to ensure compliant business operationsDeveloped, revised, and implemented SOM/Anti-Diversion Policies, Guidelines, and SOPs for continued compliance and functionalityAssisted with complex quota requests for Hobart Facility and external manufacturersContinued industry education by attending DEA Import/Export Conference and QuintilesIMS Conference
St. Louis, Missouri
Reconciled controlled substance inventories under nine (9) DEA Registrations in three (3) facilities with inventory discrepancy investigations.Supported physical inventories and destruction runs. Assisted Operations Department with preparation and reconciliation of waste while conducting an informal internal audit of the process.Generated and submitted monthly and annual ARCOS reports and annual YER reports online.Submitted controlled substance NDC and pseudo NDC numbers to DEA (ARCOS) Unit.Submitted, tracked, and audited Procurement Quota, DEA Form 222, and Import/Export of CI-II. Power of Attorney for DEA Form 222 Order Forms.Handled controlled substance ordering with continuous supplier/vendor registration validation.Assisted with Drug Code and license modifications.Developed and implemented improvements of SOP’s and internal documents for DEA compliance.Communicated with local DEA District Branch and DEA Headquarters Units.Maintained and implemented improvements in Microsoft Excel databases.Maintained proper record-keeping of DEA documentation. Supported DEA Pre-Registration inspection.Supported laboratory move of controlled substances from one facility to another and DEA license surrender.Qualified trainer and self-trainer.
Austin, Texas
Managed, reconciled controlled substance (CS) inventories under 6 DEA Registrations with inventory discrepancy investigations.Supervised, reconciled complete and accurate physical inventories, biennial and mid-year, performed role as project manager.Managed, maintained Microsoft Access CS inventory database and all associated CS databases – Microsoft Access and Excel - developed and manipulated.Generated,submitted quarterly and annual ARCOS reports and annual YER reports. Proficient in DEA (ARCOS) – PC Field Edit Program and YERS Online.Acquired CS NDC and pseudo NDC numbers from DEA (ARCOS) Unit.Completed, submitted primary DEA forms (DEA Form 222, Declaration of Import/Export, Import/Export of CI-II, etc.). Power of Attorney for DEA Form 222 Order Forms.Managed, maintained DEA recordkeeping, document archival and destruction.Handled CS ordering with continuous supplier/client registration validation.Shipped/received all CS – domestic, Import/Export and internal transfers. DOT/IATA Certified and ChemTrec Administrator for Hazardous Materials Transport Information.Assisted with Procurement Quota submissions, Drug Code requests and registration and license renewals – federal, state and local levels.Initiated/reviewed/revised SOPs and internal documents for DEA compliance.Supervised reverse distributor runs.Supported DEA Inspections, FAA Inspection, and client audits.Communicated with local DEA District branch and DEA Headquarters Units. Monitored proper security procedures to all CS storage vessels (1 vault, 6 safes and 2 cages).Trained several departments and upper level management pertaining to DEA procedures.Reviewed CS batch records.Conducted room releases for CS batches.CAPA/Non-conforming Events/Audits experienced.
Austin, Texas
Documentation compliance of Title 21 Code of Federal Regulations - Food and Drugs, cGMP practices and industry standards for Analytical and R&D Laboratories.Confirmed traceability and accuracy of cGMP documentation.Interpreted SOPs, protocols, and specifications.Managed and maintained internal databases and logbooks.Assisted with Analytical Laboratory chemical and column inventories.File management and archival.Trained peers on relevant documents.
San Marcos, Texas
Tutored Undergraduate levels
San Marcos, Texas
General Chemistry I, II & Organic Chemistry II
San Marcos, Texas
Inorganic Chemistry - Cobalt reaction, cyclic voltametry, GC/MS analyzations
Other employees you can reach at mallinckrodt.com. View company contacts for 3453 employees →
Millie Powers
Colleague at Mallinckrodt PharmaceuticalsSt Louis, Missouri, United States
View →
SK
Shelly Kilcran
Colleague at Mallinckrodt PharmaceuticalsLouisville, Kentucky, United States
View →
LB
Lia Bush
Colleague at Mallinckrodt PharmaceuticalsMilford, New Jersey, United States
View →
CK
Chris Kaye
Colleague at Mallinckrodt PharmaceuticalsSherwood, Wisconsin, United States
View →
MC
Michael Ciccone
Colleague at Mallinckrodt PharmaceuticalsGreater Chicago Area, United States
View →
JM
John Miebi Ogidi, Msc, Beng
Colleague at Mallinckrodt PharmaceuticalsSt Louis, Missouri, United States
View →
JA
Jo Ann Mcmanimie
Colleague at Mallinckrodt PharmaceuticalsSt Peters, Missouri, United States
View →
MB
Maxine Bond
Colleague at Mallinckrodt PharmaceuticalsKnightdale, North Carolina, United States
View →
DG
Dave Geiler
Colleague at Mallinckrodt PharmaceuticalsGreenville, Illinois, United States
View →
JB
Joseph Browndyke
Colleague at Mallinckrodt PharmaceuticalsWichita, Kansas Metropolitan Area, United States
View →
Activities and Societies: Chemistry Club, American Chemical SocietyMinor in Criminal Justice
Quick answers generated from the profile data available on this page.
Heather R. E. works for Mallinckrodt Pharmaceuticals.
Heather R. E. is listed as Compliance Manager | Strategic Thinker | Relationship Builder | Executor | Mentor | Pharmaceutical Industry at Mallinckrodt Pharmaceuticals.
AeroLeads has found 1 work email signal at @mallinckrodt.com for Heather R. E. at Mallinckrodt Pharmaceuticals.
AeroLeads has found 2 phone signal(s) with area code 124 for Heather R. E. at Mallinckrodt Pharmaceuticals.
Heather R. E. is based in Greater St. Louis, United States while working with Mallinckrodt Pharmaceuticals.
Heather R. E. has worked for Mallinckrodt Pharmaceuticals, Nesher Pharmaceuticals (Usa) Llc, Pharmaform, Independent, and Texas State University.
Heather R. E.'s colleagues at Mallinckrodt Pharmaceuticals include Millie Powers, Shelly Kilcran, Lia Bush, Chris Kaye, and Michael Ciccone.
You can use AeroLeads to view verified contact signals for Heather R. E. at Mallinckrodt Pharmaceuticals, including work email, phone, and LinkedIn data when available.
Heather R. E. holds Master Of Business Administration - Mba, Business Administration And Management, General from Western Governors University.
Heather R. E. is listed with skills including Pharmaceutical Industry, Dea, Quality Control, Quality Assurance, Leadership, Fda, Capa, and Validation.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contacts